There are numerous assays for total cholesterol, HDL, and triglycerides that have been approved for use in quantification of the above-mentioned analytes. The dynamic range, for example, of a Roche total cholesterol assay on a Cobas Integra® 400+ is from ˜4-800 mg/dL. Samples that read above 800 mg/dL are diluted from 1:1 to 1:10 on board the machine and reanalyzed and thus quantified. These assays typically use serum or plasma as sample types, are tested on an expensive clinical chemistry analyzer, and require a trained certified professional to operate.
In the Point-of-Care environment, cholesterol, HDL cholesterol, or triglyceride analyses are quantified rapidly (˜2 min.) using CardioChek™ test strips. There are other Point-of-Care test systems like Cholestech's cholesterol, HDL, and triglyceride tests that also can obtain results within 10 minutes. However, the limitation for both types of test is that the dynamic ranges cannot cover samples that are very high analyte concentrations and thus either are not run due to unavailability of a dilution solution or re-run using an unapproved dilution solution giving questionable results.